| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00845714004827 | 5170 | 5170 | Enhanced Anti-RNA POL lll Antibody ELISA | NYO | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody | 2 | Immco Diagnostics, Inc |
| 2 | 00845714004186 | 2510 | 2510 | Counterstain | DBL,LKJ,MOB,DHN | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTIC |
| 3 | 00845714004100 | 2284 | 2284 | DFS-70 Positive Control | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | Immco Diagnostics Inc. |
| 4 | 00845714002427 | 5152A | 5152A | B2GP1 IgA ELISA | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | Immco Diagnostics, Inc |
| 5 | 00845714002199 | 2107 | 2107 | IgA FITC Conjugate w/ Evans Blue | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTIC |
| 6 | 00845714002045 | 1108 | 1108 | ImmuGlo HEp-2 ELITE IFA | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | Immco Diagnostics, Inc |
| 7 | 00845714004391 | 1140-240X | 1140-240X | Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit | IMMCO DIAGNOSTICS | |||
| 8 | 00845714004384 | 1140-240 | 1140-240 | Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit | IMMCO DIAGNOSTICS | |||
| 9 | 00845714004353 | 2308 | 2308 | Serum Diluent | MSV,LJM | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antinuclear Antibody (Enzy System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | IMMCO DIAGNOSTICS |
| 10 | 00845714004339 | 2302-60 | 2302-60 | Buffer Diluent | LKJ | Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 11 | 00845714004322 | 2302-375 | 2302-375 | Buffer Diluent | LKJ | Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 12 | 00845714004315 | 2302 | 2302 | Serum Diluent | DBL,LKJ,MOB,DHN | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 13 | 00845714004308 | 2301 | 2301 | Phosphate Buffered Saline | DBL,LKJ,MOB,DHN | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 14 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | MVM,MSV,MST,MOB,LRM,LLL,LJM,DHR | Autoantibodies, Endomysial(Tissue Transglutaminase),System,Test,Antibodies,B2 - Autoantibodies, Endomysial(Tissue Transglutaminase),System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi),Antibodies, Gliadin,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control,Extractable Antinuclear Antibody, Antigen And Control,Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls,System, Test, Rheumatoid Factor | 2 | IMMCO DIAGNOSTICS |
| 15 | 00845714004193 | 2500LONG | 2500LONG | Coverslips | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 16 | 00845714004179 | 2506 | 2506 | Mounting Medium | MVM,DBL,LKJ,MOB,DHN | Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 17 | 00845714004162 | 2505 | 2505 | Mounting Medium | MVM,DBL,LKJ,MOB,DHN | Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 18 | 00845714004001 | 2252 | 2252 | cANCA Positive Control | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 19 | 00845714003974 | 2251 | 2251 | ARA Positive Control | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 20 | 00845714003967 | 2250G | 2250G | EMA (IgG) Positive Control | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTICS |
| 21 | 00845714003943 | 2250 | 2250 | EMA Positive Control | MVM,DBL | Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Ind Autoantibodies, Endomysial(Tissue Transglutaminase),Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 22 | 00845714003851 | 2240 | 2240 | pANCA Positive Control | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 23 | 00845714003776 | 2162-12 | 2162-12 | cANCA Slide ethanol fixed | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 24 | 00845714003769 | 2162-10 | 2162-10 | cANCA Slide | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 25 | 00845714003752 | 2162 | 2162 | cANCA Slide | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 26 | 00845714003714 | 2217 | 2217 | Pemphigold Positive | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 27 | 00845714003707 | 2216 | 2216 | Pemphigus Foliaceus Control | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 28 | 00845714003677 | 2215 | 2215 | nDNA Positive Control | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 29 | 00845714003660 | 2214 | 2214 | Pemphigus Vulgaris Positive Control | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 30 | 00845714003653 | 2161 | 2161 | Rat Kidney Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 31 | 00845714003646 | 2160 | 2160 | Primate Smooth Muscle Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 32 | 00845714003608 | 2155-18 | 2155-18 | Primate Esophagus (Distal) Slide | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTICS |
| 33 | 00845714003592 | 2155 1/10 | 2155 1/10 | Primate Esophagus (Distal) Slide | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTICS |
| 34 | 00845714003585 | 2155-8 | 2155-8 | Primate Esophagus Slide | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTICS |
| 35 | 00845714003578 | 2155-1 | 2155-1 | Primate Esophagus (Distal) Slide | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IMMCO DIAGNOSTICS |
| 36 | 00845714003561 | 2155 | 2155 | Primate Esophagus Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 37 | 00845714003554 | 2154 | 2154 | Primate/Guinea Pig Esophagus Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 38 | 00845714003547 | 2152-10 | 2152-10 | Mouse Kidney/Stomach/Liver Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 39 | 00845714003530 | 2150-21 | 2150-21 | Hep-2 Cells Slide | LKJ | Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 40 | 00845714003479 | 2100X | 2100X | IgG FITC Conjugate | MOB,DHN,DBL,LKJ | Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control,Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 41 | 00845714003462 | 2500 | 2500 | Coverslips | DBL,LKJ,MOB,DHN | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 42 | 00845714003448 | 2167-8 | 2167-8 | Mouse Kidney Slide | LKJ | Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 43 | 00845714003387 | 2186 | 2186 | pANCA Slide | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 44 | 00845714003370 | 2189 | 2189 | c+p ANCA COMBI Slide | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | IMMCO DIAGNOSTICS |
| 45 | 00845714003363 | 2190 | 2190 | Hep-2/Mouse Kidney/Stomach Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 46 | 00845714003332 | 2191 | 2191 | Hep-2/Mouse Kidney Slide | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 47 | 00845714003318 | 2200 | 2200 | Negative Control | DBL,LKJ,MOB,DHN | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclea Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control,Antinuclear Antibody, Antigen, Control,Test System, Antineutrophil Cytoplasmic Antibodies (Anca),Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 48 | 00845714003257 | 2213 | 2213 | Intercellular Positive | DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 49 | 00845714003240 | 2151-6 | 2151-6 | Crithidia Luciliae Slide | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| 50 | 00845714003226 | 2150-6 | 2150-6 | Hep-2 Cells Slide | LKJ | Antinuclear Antibody, Antigen, Control | 2 | IMMCO DIAGNOSTICS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00845714004353 | 2308 | 2308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 2 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 3 | 00845714002939 | 2513 | 2513 | Enzyme Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 4 | 00845714002793 | 2310 | 2310 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 5 | 00845714002458 | 5152S | 5152S | B2GP1 Screen ELISA | Immco DIagnostics, Inc. | IMMCO DIAGNOSTICS, INC. |
| 6 | 00845714002441 | 5152M | 5152M | B2GP1 IgM ELISA | Immco Diagnostics, Inc. | IMMCO DIAGNOSTICS, INC. |
| 7 | 00845714002434 | 5152G | 5152G | B2GP1 IgG ELISA | Immco DIagnostics, Inc. | IMMCO DIAGNOSTICS, INC. |
| 8 | 00845714002427 | 5152A | 5152A | B2GP1 IgA ELISA | Immco Diagnostics, Inc | IMMCO DIAGNOSTICS, INC. |
| 9 | 00845714000645 | 1152M | 1152M | Anti-B2-GP1 IgG Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 10 | 00845714000638 | 1152G | 1152G | Anti-B2-GP1 IgG Antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 11 | 00817273020402 | 720-830 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 12 | 00816879020243 | FGA24 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgA | HYCOR BIOMEDICAL LLC | |
| 13 | 00816879020236 | FGA23 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgM | HYCOR BIOMEDICAL LLC | |
| 14 | 00816879020229 | FGA22 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgG | HYCOR BIOMEDICAL LLC | |
| 15 | B24235B2SHUE010 | 35-B2SHU-E01 | 35-B2SHU-E01 | Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employ Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum. | Anti-Beta 2 Glycoprotein Screen ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 16 | 08426951298778 | 00009800015 | 00009800015 | 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): | HemosIL AcuStar Anti-B2GPI Domain 1 | INSTRUMENTATION LABORATORY COMPANY |
| 17 | 08426951289271 | 701250 | 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibr 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2 | QUANTA Flash® B2GP1 IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 18 | 08426951289264 | 701245 | 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2 | QUANTA Flash® B2GP1 IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 19 | 08426951289257 | 701240 | 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibra 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 | QUANTA Flash® B2GP1 IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 20 | 08426950601951 | 701188 | 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 T 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 15. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2 | QUANTA Flash® B2GP1-Domain 1Reagents | INOVA DIAGNOSTICS, INC. | |
| 21 | 08426950596820 | 701243 | 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibra 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2 | QUANTA Flash® β2GPI IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 22 | 08426950595816 | 708665.10 | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950594659 | 708675.10 | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950594543 | 708665.10L | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426950594529 | 708670.10L | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgM ELISA Control4. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator D8. 5 x1.2mL prediluted 2 GPI IgM ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 26 | 08426950594482 | 708675.10L | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 27 | 08426950594475 | 701253 | 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibra 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 | QUANTA Flash® β2GPI IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 28 | 08426950594420 | 701248 | 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 | QUANTA Flash® β2GPI IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 29 | 08426950593157 | 708675 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA | INOVA DIAGNOSTICS, INC. | |
| 30 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | INSTRUMENTATION LABORATORY COMPANY |
| 31 | 08426950496977 | 0009802012 | 0009802012 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | INSTRUMENTATION LABORATORY COMPANY |
| 32 | 08426950485971 | 708670 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2GPI IgM ELISA Control4. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator A5. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator B6. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator C7. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator D8. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgM ELISA | INOVA DIAGNOSTICS, INC. | |
| 33 | 08426950454472 | 708660 | 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point4. 1x 1.2mL prediluted β2 GPI Screening Control5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI Screening ELISA | INOVA DIAGNOSTICS, INC. | |
| 34 | 08426950451112 | 708665 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA | INOVA DIAGNOSTICS, INC. | |
| 35 | 07340058410158 | FBGP100 | FBGP100 | DIASTAT anti-B2-Glycoprotein-1 IgM | EURO-DIAGNOSTICA AB | |
| 36 | 07340058410141 | FBGP200 | FBGP200 | DIASTAT anti-B2 Glycoprotein-1 IgG | EURO-DIAGNOSTICA AB | |
| 37 | 07333066014760 | DECC055330 | DECC055330 | EliA ß2-Glycoprotein I IgM Well | EliA ß2-Glycoprotein I IgM Well | PHADIA AB |
| 38 | 07333066014753 | DECC055320 | DECC055320 | EliA ß2-Glycoprotein I IgG Well | EliA ß2-Glycoprotein I IgG Well | PHADIA AB |
| 39 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | EliA ß2-Glycoprotein I IgA Well | PHADIA AB |
| 40 | 04250289503099 | 7215US | 7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 41 | 04250289503082 | 7206US | 7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 42 | 04250289503075 | 7205US | 7205US | AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 gly AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary andsecondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 43 | 04250289502849 | 30-7215US | 30-7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 44 | 04250289502832 | 30-7206US | 30-7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 45 | 04250289502825 | 30-7205US | 30-7205US | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 46 | 04250289500951 | 3215 | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 47 | 04250289500869 | 3206 | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 48 | 04250289500852 | 3205 | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 49 | 00855360006236 | 11854 | 11854 | INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) | CORGENIX MEDICAL CORPORATION |
| 50 | 00855360006199 | 13372 | 13372 | INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |